US toughens rules for clinical-trial transparency

Good news - we’ll be getting better information on All clinical trials done!

The disappointing results of clinical trials will no longer be able to languish unpublished, thanks to rules released on 16 September by the US Department of Health and Human Services (HHS) and the US National Institutes of Health (NIH).

The long-awaited changes to the HHS clinical-trial disclosure laws requires, for the first time, that researchers report the design and results of all clinical trials and empowers the government to enforce penalties for those that do not comply. The NIH rules apply only to work done through agency grants, and include stricter reporting requirements for phase I trials. If institutions don’t follow the rules, the NIH could withdraw their funding.

“I think a lot of major universities just miss the point that if you do an experiment on a person and get consent, you really have the obligation to make the results known,” says Robert Califf, head of the US Food and Drug Administration (FDA). “This is fundamentally an ethical issue.”

Read the full story here:

7 Likes

Daze, this is a mental health support website, not a place to dump conspiracy theories. There’s a lot of places on the web for you to have these discussions and rants on. Here, keep it about schizophrenia and related disorders recovery, and you’ll find the true gem.

Back to the original thread topic…
I think it’s very good news that both successful and unsuccessful clinical trials will be required to publish their results. Transparency is key.

In science, it is equally important to understand both the successful and the failed attempts to prove a scientific hypothesis. Both sets of data are relevant and should be shared.

2 Likes

Well put wisdom beams from the moon…

Humans, blood, body, and make up will always be tested. Years ago, the scientists did it on themselves.

Or, they found a guinea pig type person who would be willing. The standards in today’s society of human rights dictate a larger adherence to trials that might place an unnecessary or unheard of cost on life.

In this country, we have Life, Liberty and the pursuit of happiness. You notice, Life comes first.

If they don’t test on humans eventually how will we ever get new meds…

1 Like

they should make them known, idk why they would want to hide the research in the first place unless it was damaging to them or they didnt get the results they wanted,

all of the clinical trials that have happened and were proven to be affective i wonder how many other trials of the same kind that had been proven ineffective you know, makes me wonder.

what do we see and what do we not see is what i’m worried about

This is exactly why they have not released all the research results in the past. If three clinical studies show success, and 8 don’t - pharma have in the past just hidden the ones that don’t - so people get a very skewed idea of how good a medication might be.

2 Likes

i think that is criminal and very misleading, how are we supposed to trust these people if they are not even being honest about their complete findings :frowning:

3 Likes

i’m a bit worried about the effectiveness of my own med now a bit, i think i’d like to see all the data on that as well, idk why, i tried to look it up but i couldnt make sense of it.